FDA Regulation 2017- 3D Printing and Medical Devices

Product Id : FDA32
Instructor : Rachelle D'Souza
Aug 25, 2017 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes



3D printing is a process that creates a three-dimensional object by building successive layers of raw material. Each new layer is attached to the previous one until the object is complete. It is a type of additive manufacturing of objects which are produced from a digital 3D file, such as a computer-aided design (CAD) drawing or a Magnetic Resonance Image (MRI).

This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.

Why Should You Attend:

The Food and Drug Administration (FDA) is responsible for the approval of medical devices in the United States of America. Today 3D printing is used in a wide variety of applications, even for the manufacture of medical devices. So, what are FDA’s current thoughts regarding the approval of 3D printed medical devices?

In this session, medical device manufacturers, software developers, engineers, validation experts, 3D printing raw material manufacturers and suppliers, regulatory and quality professionals, will be informed of FDA’s expectations regarding the design, manufacture and testing of 3D printed medical devices. Those interested in 3D printing technology will be well briefed too.

Areas Covered in the Webinar:

  • An Introduction to 3D Printing.
  • Its applications, terminology, advantages and challenges
  • An Introduction to Medical Devices & Overview of Medical Device Regulation in USA.
  • Classes and types of medical device
  • 3D Printing of Medical Devices & FDA’s current thoughts.
  • Manufacture and testing considerations for approval

Who Will Benefit:

The following professionals from the Medical Device industry will benefit from this training:

  • Manufacturers
  • Production
  • Product management
  • Research and Development
  • Software developers and vendors
  • Engineers
  • Validation experts
  • 3D printing raw material manufacturers and suppliers
  • Regulatory and quality professionals
  • Anyone interested in 3D printing technology and / or medical devices
Speaker Profile:

Rachelle D’Souza, CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities / agencies for multinational and start-up companies. Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety / pharmacovigilance and medical information systems.

At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.

Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets.

Available Options